Xcellerex Inc. | Date: 2012-02-22
Disclosed herein is a single use continuous recovery, flow-through harvest vessel and corresponding method for harvesting culture medium and simultaneously either leaving the microcarrier beads behind in the vessel or flowing microcarrier beads and medium back into a bioreactor.
Xcellerex Inc. | Date: 2012-09-20
Disclosed herein is a single use, controlled environment manufacturing module in the form of a sterile sealed bag formed of a substantially flexible material, such that the bag can be inflated and deflated for transport and/or disposal. The flexible bag has one or more access ports and connectors to accommodate a variety of biochemical or pharmaceutical manufacturing processes to be carried out within the flexible bag. The interiors of one or more disclosed modules can be connected, forming a module train.
Xcellerex Inc. | Date: 2012-10-11
Embodiments of the present invention are directed to a customizable bio-manufacturing system which includes a manufacturing space having a first air handling system for providing supply air and a second air handling system for handling exhaust air, the supply air system being optionally provided with at least one of filtration, heating, cooling and or humidity control and a plurality of portable modules provided within the manufacturing space. At least one module having an interior capable of being interconnected with another module interior and each modules interior includes one or more components to perform at least one specific task of a biological, chemical, and/or pharmaceutical manufacturing process. At least one module includes an on-board environmental control system for controlling an environment within the module and a connection means for interconnecting the module interior with another module interior. The system also includes a central controller operating to at least perform one or more of operation and information collection for the operation of at least one of the system and one or more modules.
Xcellerex Inc. | Date: 2012-01-20
Disclosed herein is a formulation capable of enhancing thermostability and shelf-life of a biological product, the formulation comprising: a tertiary amine N-oxide or a derivative thereof represented by the formulae: wherein R^(1), R^(2), and R^(3 )may be identical or different and each is a straight or branched lower alkyl group having from 1 to 4 carbon atoms; an inorganic salt; glutamic acid or a salt thereof; a polyol; a physiologically acceptable buffer, and a pharmaceutically acceptable carrier. The tertiary amine N-oxide may be trimethylamine-N-oxide, (CH_(3))_(3)NO. The formulation is useful for vaccine stabilisation.
Xcellerex Inc. | Date: 2012-01-11
Disclosed is a single-use bioreactor bag design providing substantially equivalent maximum shear rate at the impeller tip and average or bulk shear rate over a range of power per unit working volume and rpm needed for bioculture processing. The uniformity in shear profile of the bag design providing a unique advantage when used as a scale-down or scale-up platform. Also disclosed is a linearly scalable, single-use, bioreactor system for use in carrying out a scalable biomanufacturing process, the system comprising two single-use bioreactor bags of different volumes, wherein the ratio H/D of the height of the working volume H to the diameter D of the tank, or of the bag is equal to about 1.5, and the bulk shear in each of the bags is substantially constant. The disclosed small scale system models larger scale systems from both a shear/scalability/performance basis and also from a validation and regulatory basis. In summary, the 10 L bioreactor system disclosed provides for linear scalability by using the same or substantially simulating the same vessel geometry, gas sparging system, impeller shape and type, polymer composition of the flexible bag/components, process control system, and shear rates as larger 50-5000 L systems.
Xcellerex Inc. | Date: 2012-03-29
Disclosed herein is a system and method for condensing moisture in a moist gas stream entering a bioreactor or leaving a bioretractor, forming a dry gas stream for entering or leaving the bioreactor.
Xcellerex Inc. | Date: 2013-01-28
Disclosed is a sensor and housing assembly for a single-use bioreactor system, including a device for operatively associating a sensor with a flexible wall, the device comprising an internal housing portion that is removable and variably positionable on an internal surface of the flexible wall, the internal housing portion comprising a chemical detector sensor, which may be an optical chemical detector sensor.
Xcellerex Inc. | Date: 2013-10-15
The invention provides a method of increasing product yield per culture in a population of product-secreting cells bound to a scaffold, for example, a microcarrier, at least partially immersed in a culture medium in a bioreactor. The method comprising: semi-harvesting product by removing a volume of the culture medium with a first-secreted product concentration while leaving the scaffold with the bound cells in the bioreactor; re-feeding the cells by adding a fresh culture medium to increase the culture medium in the bioreactor to approximately the original volume; agitating the culture medium to allow the cells to grow and release a second-secreted product concentration; harvesting product by removing the culture medium with the second-secreted product concentration while leaving the scaffold with the bound cells behind. Also disclosed is a method of increasing virus yield per culture in a population of virus-infected cells bound to a microcarrier suspended in a culture medium.
Xcellerex Inc. | Date: 2012-12-03
A heat exchange module for use in a chemical, pharmaceutical or biological reactor system can include a body configured to be disposed in the reactor system having an inner replaceable reactant container is disclosed. The body can further include at least one thermally conductive surface adapted to contact the inner replaceable reactant container to facilitate heat transfer. Furthermore, the heat exchange module can include a heat exchanger disposed within the module body and can include a fluid circulation path through which a heat exchange fluid can be circulated.
Xcellerex Inc. | Date: 2014-02-26
Disclosed herein is provided a virus purification and formulation process for purifying a flavivirus represented by one of a a Yellow Fever Virus, Japanese Encephalitis virus, Dengue virus, and West Nile virus . The highly purified flavivirus virus product is characterized as having a low level of sucrose without significant virus loss such as that which is typically encountered by prior art virus purification processes. The disclosed process captures and purifies the virus, separating it from the host cell proteins and DNA, and leaving the host cell proteins and DNA behind. The process also can be used to inactivate and/or concentrate the virus sufficiently for use in formulations.